The present invention generally relates to a system and method for priming medical administration sets for conducting fluids to patients, and more particularly, to a system and method used for protecting and priming medical connectors.
Many self-sealing connectors presently known and used in the medical art are designed to be connected to a patient's intravenous (“IV”) or gas sampling line, drug or solution source, or other medical device such that the connector's seal operates to trap all fluid on the side of the connector toward the patient in the case of an IV line, on the side of other device such as a fluid bag in the case of a fluid source. Such seals often take the form of a valve located internally to the connector. In the case of many connectors used today, the connection tip has a Luer shape in accordance with ISO 594 whether the connection tip is male or female. In some cases, the Luer connector has an unsealed male Luer connection tip on one end that remains connected to the patient's IV line, fluid source, or other device and a self-sealing female Luer connector on the opposite free end of the connector through which a syringe or other such device may be engaged. In the case of other connectors, the connector does not have a separate male connector end but that end is instead a permanent part of the line or source.
In use, a syringe or other device having a male Luer connector is connected to the female end of the self-sealing Luer connector to push or pull fluids through the female connector, as when medications are dispensed within a patient's IV line. The syringe or other device is configured with a male Luer connector so as to engage the self-sealing female connector and cause the male Luer connector's central boss to contact the female Luer connector's seal, opening the valve and creating a fluid path through the female connector. After the necessary fluids have been dispensed or withdrawn, the syringe is removed and the internal valve of the female connector closes to reseal the female connector and trap all bodily fluids, including any just-dispensed medications, on the patient side of the connector.
Therefore, the bodily fluids are sealed off within the self-sealing female Luer connector toward the patient and away from the clinician preventing any escape of the fluids and protecting both the patient and the clinician from possible dangerous contamination from the IV administration set. Until recently, the free end of the syringe and any residual fluids remaining therein are unsealed and exposed. Rather than the self-sealing, needle-free connectors known in the art remaining attached to the syringe to trap any and all residual fluids within the syringe, they remain on the destination or source connector to trap all residual fluids there instead. However, self-sealing male connectors have been developed. Such self-sealing male connectors have internal valves and have been recognized as having many advantages including the advantage of trapping residual fluid in the fluid line or device, such as a syringe, to which they are attached when the male sealed connector is disconnected from a female connector. This is a distinct advantage when toxic medical fluids are involved.
As is well known to those skilled in the art, the use of infusion devices, including IV medical fluid administration sets and medical fluid connectors, male or female, requires that the supply tube and connectors be purged of air or “primed” prior to initiation of fluid flow into the patient. While patients can tolerate receiving a certain level of air from an IV medical fluid line, too high of a level can result in an air embolism with an adverse effect on the patient. In most cases, supply tubes and connectors initially contain a dead space volume of air. A priming procedure for purging this volume of air must typically be performed prior to connection of the supply tube and connectors to the patient.
Currently, most IV lines are primed by holding the distal fitting over a waste-bin in one hand while allowing the line to flow. The flow rate while priming is regulated with a roller clamp attached to the IV line that the user holds in his/her other hand. The user must watch the line and close the roller clamp as fluid reaches the tip of the distal fitting. Frequently, some fluid drips into the waste-bin before the clamp can be closed. This is not desirable if the fluid that drips out is either expensive or toxic. For example, in the area of nuclear medicine where radioactive isotopes are administered to patients, it is critical that exposure to the isotopes be minimized for the safety of both the care giver and the patient. Yet a further example is in the oncology area where certain drugs have great beneficial effect when confined to the circulatory system of a patient, yet are harmful to the skin or other tissue of a patient. Such drugs must be carefully controlled so that they do not reach tissues that may be harmed. Transferring such drugs from one container to another or to the patient's fluid line can be hazardous if seals are not present. The same or similar procedure would be used with other medical devices with which medical fluid is to be infused into the patient.
Initially in the case of an IV administration set, the proximal end of the supply tube is attached to the supply reservoir. The distal end of the supply tube is initially closed off using a tube clamp. For priming the supply tube, the tube clamp is adjusted, opening the supply tube and initiating liquid flow from the supply reservoir through the supply tube. This forces the dead volume of air initially contained in the supply tube out the distal end of the supply tube. When liquid reaches the distal end of the supply tube, the air in the supply tube has been purged. The supply tube is then closed off by adjusting the tube clamp and the distal end of the supply tube is attached to the patient interface device. It is at this point that typically some fluid drips out of the line before it can be closed; i.e., the undesirable situation discussed above.
In the case of sealed male Luer connectors, i.e., male connectors with internal valves, some such connectors draw fluid back into the connector upon de-activation to the non-flow configuration. This feature has been designed into such connectors for the purpose of removing any stray medical fluid from the tip of the connector during the time it is being disconnected from a female connector so that a clinician will not inadvertently come into contact with such fluid. This is a particular advantage when toxic fluids are to be administered to the patient. While this feature provides a recognized advantage during the time the connector is in use, it must be also considered during the priming process. Those skilled in the art have recognized the need for a priming system and method for such connectors.
As another consideration, patients requiring therapy have often been placed in a position where their normal defenses against microorganisms are compromised. As a result, the patients may develop nosocomial infections while being treated for another disease during therapy. As has been recognized, a possible cause of nosocomial infections can be the tubing lines and devices of medical administration sets, especially in the area of IV therapy. This is one reason why most IV administration sets (IV tubing with connectors) are carefully cleaned before use and are discarded every seventy-two hours. Protective measures, such as a protective cap mounted to the Luer tip, taken before the use of connectors are widely appreciated as having a preventive effect on infections for patients. Additionally, Luer fittings are susceptible to being damaged through rough handling and protective caps would not only lower the risk of infection to the patient, but would also lessen the risk of damage to a male Luer connection tip itself.
Hence, those skilled in the art have recognized a need for a protective cap for a self-sealing male connector to lessen the risks of damage to the connector and the risk of infection to patients. Further, those skilled in the art have recognized the need for a system and method for priming self-sealing male Luer connectors so that no liquid is wasted or exposed to clinicians. The present invention fulfills these needs and others.